Phase 2
N=62
Non-Invasive Diagnosis of Pulmonary Vascular Disease Using Inhaled 129Xe Magnetic Resonance Imaging
Pulmonary Vascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT03078192 ↗Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcome: Primary: Participants Determined to be True Positives for Pulmonary Arterial Hypertension — 10; 15; 10; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- GE-141, Hyperpolarized 129Xenon gas (Drug); MRI (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bastiaan Driehuys
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants Determined to be True Positives for Pulmonary Arterial Hypertension |
10; 15; 10; 5; 0; 3 | — |
Summary
This study seeks to deploy several forms of 129Xe MRI contrast as well as emerging conventional proton MRI technqiues for imaging lung structure and perfusion. Specifically, the 129Xe MRI scans will provide 3D images of ventilation and gas exchange, and spectroscopic indices will be evaluated to test gas exchange dynamics with high temporal resolution. The conventional 1H MRI scans will include a free-breathing ultra-short echo time (UTE) scan that provides images similar to that of a CT scan. In addition, to characterize perfusion and vascular dimensions directly, patients will undergo a gadolinium-enhanced perfusion scan.
Eligibility Criteria
Inclusion criteria
- Outpatients of either gender, age > 18
- Willing and able to give informed consent and adhere to visit/protocol schedules. (Consent must be given before any study procedures are performed)
- Women of childbearing potential must have a negative urine pregnancy test. This will be confirmed before participation in this investigational protocol.
- Either has a diagnosis of PAH, isolated left heart disease or lung disease (chronic obstructive pulmonary disease or interstitial lung disease) or CTEPH using established clinical criteria.
- Patients undergoing right heart catheterization for evaluation of PAH or other cardiac or pulmonary disease for MRI scans
Exclusion criteria
- Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements
- Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine)
Data sourced from ClinicalTrials.gov (NCT03078192). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.